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NeuroGlove PTSD Study

Sponsor
NeuroGlove LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT06050590
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
12.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.

Condition or Disease Intervention/Treatment Phase
  • Device: NeuroGlove
 N/A

Detailed Description

This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.

There will be a single cohort in the study consisting of the subjects with PTSD who will receive treatment with NeuroGlove.

The trial is intended to evaluate the impact of the device use on active PTSD symptoms and subject sense of well-being.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
NeuroGloveNeuroGlove
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness
Actual Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: NeuroGlove Treatment Arm

Study participants undergoing treatment using the NeuroGlove.

Device: NeuroGlove
Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.

Outcome Measures

Primary Outcome Measures

  1. PTSD Symptom Reduction [4 weeks]

    Change in PTSD symptoms and subject's sense of well-being

  2. Portion of participants with adverse events [4 weeks]

    Rate and severity of adverse events related to the use of the NeuroGlove.

Secondary Outcome Measures

  1. PTSD Symptom Severity [4 weeks]

    Change in severity of symptoms related to PTSD using NSESSS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.

  • Men and women ≥18 and <85 years of age.

  • Carry an active diagnosis of PTSD.

  • Suffer from PTSD symptoms that impact subject's daily activities and quality of life.

Exclusion Criteria:

  • Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)

  • Subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.

  • Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 NeuroGlove Saint Paul Minnesota United States 55102

Sponsors and Collaborators

  • NeuroGlove LLC

Investigators

  • Principal Investigator: Eric Nussbaum, MD, NeuroGlove LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NeuroGlove LLC
ClinicalTrials.gov Identifier:
NCT06050590
Other Study ID Numbers:
  • REG-1003
First Posted:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by NeuroGlove LLC
PTSD
Post Traumatic Stress Disorder
Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 22, 2023